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ClinicalTrials.gov ID

NCT07127146

Lead Sponsor

Hospices Civils de LyonOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

55Estimated

Last Update Posted

Aug 17, 2025Actual

Start Date

Oct 1, 2025Estimated

Primary Completion Date

Oct 1, 2025Estimated

Completion Date

Oct 1, 2025Estimated

Official Title

Role of Opioidergic and Noradrenergic Systems in Central Parkisonian Pain

Brief Summary

The goal of this study is to evaluate the differences in functional physiopathology of the opioid and noradrenergic systems between Parkinson's patients with central pain and Parkinson's patients without central pain. Using PET-MRI data, investigators aim to observe opioids receptors availability using [11C]Carfentanil (µ opioid receptor agonist) and altered α2-AR density with [11C]Yohimbine (adrenergic α2 receptor antagonist).

• Parkinson Disease

• PET-MRI exam with administration of [11C]Carfentanil
• PET-MRI exam with administration of [11C]Yohimbine

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

Yes

Eligibility Criteria

Inclusion Criteria:

• Diagnosis of Parkinson's disease based on MDS-UPDRS criteria (Group 1 and 2)
• Dopaminergic therapy stable with stable dose for at least 4 weeks prior to J0
• Affiliate to a social security or similar system
• Having given written consent to participate in the study, free and informed.
• Having chronic pain more than 3 month (Group 1)
• Without chronic pain (Groupe 2 and 3)
• Having central pain using specific algorithm (Marques et al., 2019)
• Having pain intensity at least 4 on VAS (Visual Analogue Scale) during the last month (Group 1)
• Having pain intensity lower than 3 on VAS (Visual Analogue Scale) during the last month (Group 2 and 3)

Exclusion Criteria:

• Having atypical Parkinson's disease (Group 1 and 2)
• Parkinson's disease with disabling dyskinesia and/or severe tremor (Group 1 and 2)
• Any contraindications to having a brain MRI or PET scan (e.g., pacemaker, metal foreign body, claustrophobia, deep brain stimulation or apomorphin pump unable to be turn off)
• History of head trauma with loss of consciousness lasting more than 30 minutes
• Not agreeing to be informed in the event of incidental discovery of an abnormality on MRI or during neuropsychological assessment
• Presence of cognitive dysfunction (defined as MoCA score < 24)
• Severe depression (BDI > 29)
• unable to stop the opioid treatment the week before the imaging exam ( e.g., Antarène codéine, Claradol codéine, Codoliprane, Dafalgan codéine, Euphon, Klipal, Lindilane, Néo-codion, Paderyl, Prontalgine, Pulmoserum, Tussipax ; Opium : Izalgi, Lamaline, Colchimax, Dropizal ; Morphine : Actiskenan, Moscontin, Oramorph, Sevredol, Skenan ; Buprénorphine : Bupensan, Buvidal, Orobupre, Sixmo, Suboxone, Subutex, Temgesic, Zubsolv ; Dihydrocodéine : Dicodin ; Hydromorphone : Sophidone ; Nalbuphine : Nalpain ; Fentanyl : Abstral, Actiq, Breakyl, Durogesic, Effentora, Instanyl, Matrifen, Pecfent, Recivit ; Méthadone : Methadone AP-HP, Zorvon ; Oxycodone : Oxsynia, Oxycontin, Oxynorm, Oxynormoro ; Tramadol : Biodalgic, Contramal, Ixprim, Monoalgic, Monocrixo, Orozamudol, Skudexum, Topalgic, Zaldiar, Zamudol, Zumalgic)
• unable to stop any treatment
• Treated with level 1 analgesics (NSAIDs, acetaminophen) or coanalgesics (antidepressants, antiepileptics) unless treatment has been stable for at least 4 weeks prior to the study and does not interfere with the noradrenergic system (list above).
• Presenting or having presented a dependence on any addictive substance according to DSM-IV-TR criteria, with the exception of tobacco.
• Having used recreational drugs interfering with the opioid and noradrenergic systems (cannabis, CBD, opiates, MDMA, ecstasy) in the last 3 months or chronic use
• Pregnant women, women in labor or nursing mothers
• Persons deprived of their liberty by judicial or administrative decision
• Under psychiatric care
• Admitted to a health or social institution for purposes other than research
• Under legal protection (guardianship, curatorship)
• Participant in another interventional study with an exclusion period still in progress at pre-inclusion
• Having exceeded the annual amount of compensation authorized for participation in research protocols

Primary Purpose

Basic Science

Allocation

Non-Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Hospices Civils de LyonOTHER

christine.brefel-courbon@univ-tlse3.fr05 61 77 25 35